Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04711135 · OUTCOME

Calculated Probability of Exceeding the Kidney and Bone Marrow External Beam Radiation Therapy (EBRT) Threshold

Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs · Source last updated 2026-02-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
probability
Interval / dispersion
Not reported
Time frame
After 4 cycles of 7.4 GBq/200 mCi; each cycle is 8+/-1 weeks

What was measured

A comparative assessment of dosimetry for organs at risk specifically kidneys and bone marrow, was performed between adolescent patients with GEP-NETs and PPGLs as a pooled cohort and adult patients using the extrapolation model developed for the clinical study to confirm the probability of exceeding 29 Gy (kidneys) \& 2 Gy (bone marrow) thresholds.

Analysis population: Dosimetry Analysis Set (DAS) consisted of all participants who had at least one valid dosimetry measurement. Original NETTER-P protocol intended to conduct separate analyses for the GEP-NET and the PPGL populations. However, the protocol was amended to allow combined analyses for dosimetry across the two patient indications. The number of patients was equal 10, since data from one patient was excluded from the dosimetry modeling analysis, due to technical issues during image acquisitions.

Groups in this outcome

GEP-NET and PPGL

All eligible participants with Gastroenteropancreatic neuroendocrine tumor (GEP-NET) and Pheochromocytoma and paraganglioma (PPGL) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
GEP-NET and PPGL10

Reported measurements

Observed: Kidney (Probability (%) >29 Gy)
Values in probability · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEP-NET and PPGL20.0Not reportedNot reportedNot reportedNot reported
Observed: Bone Marrow (Probability (%) >2 Gy)
Values in probability · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GEP-NET and PPGL0.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20.0
    title
    Observed: Kidney (Probability (%) >29 Gy)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
    title
    Observed: Bone Marrow (Probability (%) >2 Gy)
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
A comparative assessment of dosimetry for organs at risk specifically kidneys and bone marrow, was performed between adolescent patients with GEP-NETs and PPGLs as a pooled cohort and adult patients using the extrapolation model developed for the clinical study to confirm the probability of exceeding 29 Gy (kidneys) \& 2 Gy (bone marrow) thresholds.
groups
  1. description
    All eligible participants with Gastroenteropancreatic neuroendocrine tumor (GEP-NET) and Pheochromocytoma and paraganglioma (PPGL) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
    id
    OG000
    title
    GEP-NET and PPGL
param Type
NUMBER
population Description
Dosimetry Analysis Set (DAS) consisted of all participants who had at least one valid dosimetry measurement. Original NETTER-P protocol intended to conduct separate analyses for the GEP-NET and the PPGL populations. However, the protocol was amended to allow combined analyses for dosimetry across the two patient indications. The number of patients was equal 10, since data from one patient was excluded from the dosimetry modeling analysis, due to technical issues during image acquisitions.
reporting Status
POSTED
time Frame
After 4 cycles of 7.4 GBq/200 mCi; each cycle is 8+/-1 weeks
title
Calculated Probability of Exceeding the Kidney and Bone Marrow External Beam Radiation Therapy (EBRT) Threshold
type
SECONDARY
unit Of Measure
probability

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice